Seattle-based Adaptive Biotechnologies Corp. reported a collaboration with Glaxosmithkline plc (GSK), of Brentford, U.K., to use its Clonoseq assay to assess minimal residual disease in GSK’s portfolio of hematology products.
Garden City, N.Y.-based Beyond Air Inc., which is focused on developing inhaled nitric oxide for the treatment of patients with respiratory conditions, reported the submission of a premarket approval application to the U.S. FDA for its Lungfit PH to treat persistent pulmonary hypertension of the newborn.
Co-Diagnostics Inc., of Salt Lake City, said that a recent company whitepaper demonstrates that the Coprimer platform technology can be used to identify the presence of SARS-CoV-2 in human saliva samples without first requiring RNA extraction of the sample and can do so while providing low limits of detection.
Lexington, Mass.-based Csa Medical Inc. said that more than half of the subjects in a 32-patient study characterizing the mechanism of action of Metered Cryospray with the Rejuvenair system in patients with chronic bronchitis have been enrolled.
Exuma Biotech Corp., of West Palm Beach, Fla., presented preclinical data on its next-generation rapid point-of-care (rPOC) subcutaneous, autologous CAR-T platform at the Society for Immunotherapy of Cancer annual meeting and preconference. The platform is made possible by viral vectors that are engineered to display T cell-activating elements on the viral envelope and to encode “drivers” of T cell engraftment, in addition to chimeric antigen receptors. According to the poster presentation, animal models reveal that exposure of peripheral blood to vectors for just four hours, followed by subcutaneous injection to create a synthetic lymph node, resulted in robust CAR-T cell expansion (>10,000 fold) with regression of established tumors. Administration of the same products intravenously in the same animal model did not support significant CAR-T cell expansion or control tumor growth.
Monroe, La.-based Lumen Technologies, which offers a hand-held metabolic tracking device, and Garmin International Inc., a unit of Olathe, Kan.-based Garmin Ltd., have launched a Connect IQ Lumen App and Garmin Health application programming interface integration, allowing users to better understand the impact of fitness and nutrition decisions on their body in real time.
Qiagen NV, of Hilden, Germany, has launched the portable, digital Qiareach SARS-CoV-2 Antigen test in the U.S. It can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in two to 15 minutes. The company submitted the to the U.S. FDA for emergency use authorization and is seeking CE-IVD registration in the E.U. and other markets, with approvals expected as early as the end of this year.
Stockholm-based Raysearch Laboratories AB said its treatment planning system, Raystation, is now in clinical use with boron neutron capture therapy, along with a treatment machine from Sumitomo Heavy Industries Ltd., of Tokyo, at two cancer clinics in Japan.
Solace Therapeutics Inc., of Arlington Heights, Ill., said it has enrolled the first patient in the VESAIR clinical trial to evaluate the safety and efficacy of the Vesair bladder control balloon procedure, an office-based treatment for female stress urinary incontinence.
Toronto-based Spectral Medical Inc., a late-stage theranostic company, said the Sami renal replacement therapy machine, manufactured and commercialized by its wholly owned subsidiary, Dialco Medical Inc., was successfully implemented and managed remotely to treat 23 patients at the University of Michigan Medical Center in April, during the early weeks of the COVID-19 pandemic. The clinical deployment was reported in the Journal of Blood Purification.
Spine Innovations, of Mulhouse, France, reported that it is now a fully independent company, following the acquisition of its parent company Fh Orthopedics, of Heimsbrun, France, by Tokyo-based Olympus Corp.
Stryker Corp., of Kalamazoo, Mich., said it has completed its acquisition of Amsterdam-based Wright Medical Group NV. The cash tender offer for all outstanding ordinary shares of Wright Medical for $30.75 per share, without interest and less applicable withholding taxes, by Stryker BV, an indirect, wholly owned subsidiary of Stryker, expired at 5 p.m. ET Nov. 10.